Astonishingly, in an election year and at a time of unprecedented partisanship, this past June, Congress adopted significant reforms to the Toxic Substances Control Act (TSCA) with sweeping support from both sides of the aisle. In the words of the U.S. Environmental Protection Agency (EPA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act addresses “fundamental flaws” in TSCA that have hampered the agency’s ability to restrict and otherwise regulate dangerous chemicals. Although there are many facets to the new law, perhaps none are more central to its future success than the new standards to be utilized by EPA for evaluating chemical risk and regulating chemicals. The reformed TSCA not only mandates that eventually all chemicals be prioritized for review by EPA, but also changes the standards for evaluating chemical risk and for the promulgation of rules to prohibit and limit the use of chemicals found to present an unreasonable risk of injury to health or the environment. When these new standards are compared with the prior law of the past 40 years, it is apparent that major changes in our nation’s chemical regulation are in store.

By most accounts, TSCA largely failed as an effective mechanism for imposing rules to prohibit or limit chemical use. Despite TSCA’s enactment in 1976, EPA has only imposed restrictions on a handful of chemicals under TSCA Section 6 pertaining to the tens of thousands of chemicals that existed in EPA’s chemical inventory at the time of its original enactment. These are polychlorinated biphenyls (PCBs), chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium, and it bears mentioning that the statute specifically required EPA to regulate PCBs. Among the factors perceived to have hobbled EPA’s effort to regulate a greater number of chemicals were the burdens imposed upon the agency when evaluating chemical risk and further impediments for adopting rules to protect against such risks. For one, Section 6 was interpreted as imposing a balancing test on EPA that included consideration of costs when evaluating a chemical’s risk. Moreover, when promulgating a rule to protect against an unreasonable risk of a chemical, Section 6 required EPA to use the least burdensome requirements. These hurdles ultimately proved fatal to EPA’s attempt to ban asbestos-containing products. In 1991, EPA’s final rule that prohibited the manufacture, importation, processing, and distribution of asbestos in almost all products was overturned by the Fifth Circuit Court of Appeals in Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991). In doing so, the Court concluded that EPA had failed to present sufficient evidence to justify its asbestos ban since it failed to consider all necessary evidence, including costs, and failed to adequately address the least burdensome alternatives under Section 6 of TSCA. Thereafter, in the years following the court’s decision, EPA did not move to regulate any other existing chemicals under its TSCA authority. This stalemate ultimately contributed to the chorus for TSCA reform.

The recently enacted TSCA reforms significantly amend the provisions of Section 6 for evaluating chemical risk and for promulgating rules to protect against such risks. In particular, EPA must now conduct risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment without consideration of costs or other nonrisk factors. EPA’s evaluation of chemical risk has also been broadened to now consider unreasonable risks to potentially exposed or susceptible subpopulations, which include individuals who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical, such as infants, children, pregnant women, workers and the elderly.

Although cost does not play a role in the evaluation of chemical risk anymore, EPA still considers cost among a host of other factors when promulgating protections for chemicals found to present an unreasonable risk. However, EPA is no longer mandated to promulgate the least burdensome alternative that long hampered its previous regulatory efforts. Under the new regime, which includes vestiges of the prior standard, when promulgating a rule for regulating chemicals, and to the extent practicable when selecting among prohibitions and other restrictions, EPA must consider:

  • The effects and magnitude of the exposures for human beings and the environment;
  • The benefits of the chemical substance or mixture for various uses;
  • The reasonably ascertainable economic consequences of the rule, including (a) consideration of the likely effect on the national economy, small business, technological innovation, the environment and public health and (b) the costs, benefits and cost effectiveness of the proposed regulatory action and of one or more primary alternative regulatory actions; and
  • To the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute.

Further, while EPA previously lacked a defined mandate to act, the recently enacted TSCA reforms now impose deadlines to tackle the backlog of chemical risk evaluations and deadlines for EPA to regulate chemicals when found to pose an unreasonable risk. In particular, after publishing a final risk evaluation determining that a chemical presents an unreasonable risk of injury to health or the environment, EPA has one year to propose a rule and two years to publish a final rule. This deadline may only be extended by a total of two additional years. Any rule adopted by EPA to ban or phase-out a chemical must also specify mandatory compliance dates which must be as soon as practicable, but no later than five years after promulgation of the rule. Only limited exemptions to these strict timeframes are allowed under the new law, which require EPA to find:

(1) The specific condition of chemical use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure;

(2) Compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or

(3) The specific condition of use, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety.

EPA has a lot of catching up to do after decades of stagnation, but there is little doubt that the recently enacted TSCA reforms pave the way for significant changes to come. While Congress may have come together to finally reform TSCA, it is nonetheless likely that there will be considerable debate when TSCA’s new provisions are employed by EPA. Stakeholders should therefore be prepared to participate in the newly enacted processes under TSCA’s reforms to ensure that EPA’s forthcoming decisions on chemical risk and its rules to address such risks are appropriately vetted and well-reasoned.

This article was originally published in Environmental Leader, October 7, 2016.